Presenter:
Jesse Coe
Associate Director of Business Development
KBI Biopharma
Overview
In this webinar, Jesse explores the complexities of product characterisation and control strategy, focusing on Antibody Drug Conjugates (ADCs). Drawing from his extensive experience at KBI Biopharma, he highlights the importance of regulatory compliance, quality assurance, and analytical techniques in biopharmaceutical development.
Key Insights from Jesse’s Talk:
- Product Characterisation & Regulatory Impact: Comprehensive characterisation supports IND and BLA filings.
- Critical Quality Attributes (CQAs): Identifying and controlling attributes that affect product efficacy and safety.
- Analytical Techniques for ADCs: Understanding DAR (Drug-to-Antibody Ratio), glycan distribution, and stability assessments.
- Aggregation & Degradation Pathways: Mitigating risks in biologics to ensure therapeutic effectiveness. Impact and Future Directions:
- Advanced control strategies improve patient safety and drug efficacy.
- Emerging technologies streamline biological development and regulatory filings.
Discover how Jesse’s insights help shape better biopharmaceutical development strategies and contribute to the future of ADC therapies!
